N/A
N=649
Evaluation of a Mobile Therapy for Elevated Depressive Symptoms
Depressive Symptoms · Depression
Bottom Line
View on ClinicalTrials.gov: NCT04463914 ↗Enrolled (actual)
649
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Mean Score of Depressive Symptoms — -5.95; -11.24; -10.69 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral Activation Therapy app (Behavioral); Behavioral Activation Therapy app + EHR (Behavioral); Treatment as Usual (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Score of Depressive Symptoms |
-5.95; -11.24; -10.69 | — |
Summary
The purpose of this research study is to evaluate a mobile application (app) for depression treatment. Participants will be randomly assigned to either receive the mobile app, "Moodivate", or not. If provided with Moodivate, participants will be asked to use the app regularly, at least once per day, throughout the study duration. Participants will be asked to complete electronic questionnaire measures throughout the study period. Participation in this study will take about 12 weeks.
Eligibility Criteria
Inclusion Criteria
- Elevated depressive symptoms, defined as a score of > 10 on the Patient Health Questionnaire-9 (PHQ-9)57
- Age 18+
- Currently own an iOS- or Android-compatible smartphone
- Report willingness to utilize a mobile app for the treatment of depressed mood (response of "yes" on yes/no item)
- Have a current, valid e-mail address that is checked at least once per day or have regular access to text messages (to access follow-up assessments)
- Enrolled in Epic's MyChart program
- English fluency
Exclusion Criteria
- Current suicidal ideation at study screening, defined as a response >1 (several days) on item nine of the PHQ-9 ("Over the last two weeks, how often have you been bothered by thoughts that you would be better off dead, or of hurting yourself?")
Data sourced from ClinicalTrials.gov (NCT04463914). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.